Suture passer

ABSTRACT

Sutures can be placed in difficult to access areas of the human body with devices, and related methods, utilizing a suture carrier with a sharpened tip and a notch for holding a formed suture tip. The devices and methods can be used in conjunction with both endosurgical and traditional open surgery

TECHNICAL FIELD

[0001] The invention relates to devices and methods for placing sutures.

BACKGROUND INFORMATION

[0002] Suturing of body tissue is a time consuming aspect of manysurgical procedures. For many surgical procedures, it is necessary tomake a large opening in the human body to expose the area that requiressurgical repair. There are instruments available that allow for viewingof certain areas of the human body through a small puncture woundwithout exposing the entire body cavity. These instruments, calledendoscopes, can be used in conjunction with specialized surgicalinstruments to detect, diagnose, and repair areas of the body thatpreviously required open surgery to access.

[0003] Some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. Also, many of the instruments are limited by the waythey grasp tissue, apply a suture, or recapture the needle and suture.In addition, the needle can become separated from the needle-drivingdevice and lost within a patient. Furthermore, many of the instrumentsare complicated and expensive to use due to the numerous parts and/orsubassemblies required to make them function properly.

SUMMARY OF THE INVENTION

[0004] The suture passer of the present invention eliminates the needfor a preassembled needle and suture and eliminates the possibility ofneedle loss during suturing. This is accomplished by eliminating the useof a loose needle or any needle at all. Specifically, the suture passeruses a suture with a formed tip that engages a suture carrier. Thesuture carrier is coupled to the suture passer and has a sharpened endfor piercing tissue. The suture carrier also has a notch for carryingthe formed tip of the suture. When the device is actuated, the suturecarrier pierces the tissue and carries the formed tip through the tissueand into a formed tip catch. The suture carrier is then retractedleaving the suture intact.

[0005] In one aspect, the invention relates to a suturing instrument.The suturing instrument includes an elongate body member, a suturedeployment system disposed at a distal portion of the elongate bodymember, and a catch to receive and retain a formed suture tip. Thesuture deployment system includes a suture carrier having a sharpeneddistal end for tissue penetration and a notch for holding the formedsuture tip.

[0006] In some embodiments, the suturing instrument may include adeployment controller having a proximal end and a distal end. Thedeployment controller extends substantially along a longitudinal axis ofthe elongate body member to the distal portion of the elongate bodymember, where the distal end of the deployment controller is coupled tothe suture carrier and moves the suture carrier between a retractedposition and a deployed position. The proximal end of the deploymentcontroller may be coupled to an actuator. In some embodiments, thedeployment controller guides the suture carrier along a path thatincludes a proximal curved path segment such that the suture carrierinitially travels away from the elongate body member and then towardsthe elongate body member.

[0007] In another aspect, the invention relates to a suturing instrumentincluding a suture carrier and a body member defining a suture exit portand a suture carrier channel. The suture carrier includes a sharpeneddistal end for tissue penetration and a notch for holding a formedsuture tip. The suture carrier is movably positioned in the suturecarrier channel between a retracted position within an interior regionof the body member and a deployed position exterior to the body member.The suture carrier is configured within the suture carrier channel suchthat the suture carrier exits the interior region of the body memberthrough the suture exit port.

[0008] In yet another aspect, the invention relates to a suturinginstrument including an elongate body member having a longitudinal axisand a distal tip suture deployment assembly joined with a distal end ofthe elongate body member such that the distal tip assembly is free torotate axially about the longitudinal axis of the elongate body member.The distal tip suture deployment assembly includes a suture exit portand a curved suture carrier channel formed in the distal tip suturedeployment assembly, a curved suture carrier movably positioned in thecurved suture carrier channel, a suture with a formed tip coupled to thesuture carrier, and a deployment controller including a proximal end anda distal end. The deployment controller extends substantially along thelongitudinal axis of the elongate body member to the distal end of theelongate body member, where the distal end of the deployment controlleris coupled to the distal tip suture deployment assembly and moves thecurved suture carrier through the curved suture carrier channel as thedeployment controller moves between a retracted position and a deployedposition. Additionally, the proximal end of the deployment controllermay be coupled to an actuator.

[0009] In still another aspect, the invention relates to a suturinginstrument including a body member defining an exit port and a carrierchannel, a carrier movably positioned in the carrier channel, and asurgical needle permanently fixed on a distal end of the carrier. Thecarrier has a retracted position within an interior region of the bodymember and a deployed position exterior to the body member. The carrieris configured within the carrier channel such that the carrier exits theinterior region of the body member through the exit port. Thepermanently fixed needle may include a notch for holding a formed suturetip. In addition, the exit port, suture carrier channel, and suturecarrier can be located in a distal tip assembly coupled to the bodymember, and the distal tip assembly can be coupled to the body membersuch that the distal tip assembly is free to rotate axially about alongitudinal axis of the body member.

[0010] Various embodiments according to any of the foregoing aspects ofthe invention can include the following features. A suture can include aformed tip, which may be permanently fixed to an end of the suture. Theformed tip of the suture can insert into the suture carrier notch. Also,the formed tip can be plastic, metal, or polymer compound. In addition,the suturing instrument can include a catch to receive and retain theformed suture tip, where the catch is positioned on the body member suchthat a distal segment of the suture carrier's path is intercepted by thecatch. Additionally, the suturing instrument may include a second suturecarrier and a second exit port. Further, the deployment controller maybe coupled to the suture carrier with a flexible driver member. Theflexible driver member may be manufactured of an alloy that includes atleast or exclusively nickel and titanium.

[0011] An additional aspect of the invention relates to a method forplacing a suture in tissue. In accordance with the method, inserting asuturing instrument enclosing a suture carrier having a sharpened endfor tissue penetration and a notch for holding a formed suture tip,deploying the suture carrier out of the suturing instrument through anexit port such that the suture carrier exits an interior region of thesuturing instrument through the exit port along a path which approachesbeing substantially tangential to an outer surface of the suturinginstrument surrounding the exit port, and capturing a suture carried bythe suture carrier in a catch that receives and retains the formedsuture tip. The suture carrier is movably positioned within a suturecarrier channel adjacent the tissue to be sutured.

[0012] These and other objects, along with advantages and features ofthe present invention herein disclosed, will become apparent throughreference to the following description, the accompanying drawings, andthe claims. Furthermore, it is to be understood that the features of thevarious embodiments described herein are not mutually exclusive and canexist in various combinations and permutations.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In the drawings, like reference characters generally refer to thesame parts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention. In the followingdescription, various embodiments of the present invention are describedwith reference to the following drawings.

[0014] FIGS. 1A-1H are cutaway views illustrating the general structureand operation of one embodiment of the present invention.

[0015] FIGS. 2A-2D and 2F are perspective views of various embodimentsof sutures and formed suture tips.

[0016]FIG. 2E is a cross-sectional view of one embodiment of a sutureand formed tip.

[0017]FIGS. 2G and 2H are end views of the embodiment of a suture andformed tip shown in FIG. 2F.

[0018]FIG. 3A is a partial-cutaway view of a suture carrier.

[0019]FIG. 3B is an enlarged perspective view of the suture carrier ofFIG. 3.

[0020]FIG. 4 is a perspective view of a catch and a suture with a formedsuture tip.

[0021]FIG. 5 is a perspective view of an alternate catch mechanism witha suture carrier.

[0022]FIGS. 6A and 6B are partial cutaway views illustrating the generalstructure and operation of one embodiment of a suture delivery andcapture system.

[0023]FIGS. 6C and 6D are partial cutaway views illustrating the generalstructure and operation of an alternate embodiment of a suture deliveryand capture system.

[0024]FIG. 7 is a partial side view taken along line 7-7 of FIG. 6A andillustrating the formed suture tip catch.

[0025]FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 7.

[0026]FIG. 9A is an exploded illustrating the general structure of analternate embodiment of the suture carrier and guide track.

[0027]FIG. 9B is a perspective view illustrating the general structureof an alternate embodiment of the suture carrier of FIG. 9A.

[0028]FIG. 10 is a cross-sectional view illustrating the relationshipbetween the suture carrier and guide track.

[0029]FIGS. 11A and 11B are cross-sectional views of two alternatedesigns of the suture carrier taken along line 11-11 of FIG. 9A.

[0030]FIG. 12 is a cross-sectional view of the suture carrier and guidetrack taken along line 12-12 of FIG. 10.

[0031]FIG. 13 is a cross-sectional view of the suture carrier and guidetrack taken along line 13-13 of FIG. 10.

[0032]FIG. 14 is an elevation of another embodiment of the presentinvention.

[0033]FIG. 15 is a cutaway view illustrating the general internalstructure of the embodiment shown in FIG. 14.

[0034]FIG. 16 is a cutaway view of the head of the embodiment shown inFIGS. 14 and 15.

[0035] FIGS. 17A-17D are cutaway views illustrating the operation of theembodiment shown in FIGS. 14-16.

[0036] FIGS. 18A-18B are partial-cutaway views of the distal tip of oneembodiment of a suturing device and illustrating the general structureand operation of the axial articulation of the suture driver head.

[0037] FIGS. 19A-19C are perspective views of one embodiment of asuturing instrument of the invention featuring an elbow-shaped,elongated body member with a rotatable head shown in various rotatedpositions.

[0038] FIGS. 19D-19F are partial-cutaway views illustrating some detailsof the rotatable head shown in FIGS. 19A-19C and featuring a suturecarrier, a catch, and engaging elements.

DESCRIPTION

[0039] Embodiments of the present invention are described below. It is,however, expressly noted that the present invention is not limited tothese embodiments, but rather the intention is that modifications thatare apparent to the person skilled in the art are also included.

[0040] FIGS. 1A-1H illustrate the general structure and operation of oneembodiment of the present invention. A device 2 according to the presentinvention incorporates a length of suture material 4 with a formed tip 6on each end. Suture carriers 10 hold the formed tips 6. The suturecarriers 10 and formed tips 6 are deployable out of a housing 12 andinto tissue surrounding a puncture wound 14. Deployment is via anactuator, such as a plunger 3, coupled to a pair of rigid drivingmembers 5, which are suitably attached to the suture carriers 10. Inthis disclosed embodiment, the plunger 3 is pushed, simultaneouslydriving the suture carriers 10 and formed tips 6 into a catch mechanism16. The suture carriers 10 are then retracted back into the housing 12.The housing 12 (now containing only the suture carriers 10 without theformed tips 6) and the catch mechanism 16 with the captured formed tips6 are retracted as shown in FIGS. 1G and 1H. With a loop of suture 4having thus been placed in the tissue surrounding the puncture wound 14,the suture device 2 is removed from the wound 14, thereby pulling theends of the suture 4 with it (FIG. 1H). Closure of the puncture wound 14is accomplished by cutting the suture 4 to disconnect the formed tips 6from the installed suture 4, tying a knot with the now-free ends of theinstalled suture 4, and pushing into the wound 14 the knot and anysuture 4 extending out of the wound 14. Superficial closure is thenperformed by normal means according to a surgeon's preference.

[0041] The suture carrier path shown in FIGS. 1A-1H is generallycircular; however, it is contemplated that the above embodiment may bemodified to include suture carrier paths other than circular, such ashelical, elliptical, or straight, by modification of the suture carriersand/or the suture carrier guides defined by the housing 12. It is alsopossible to adapt the above configuration to allow each of the suturecarriers to be actuated and driven independently by dividing thedeployment controls and the suture carrier drivers into separate leftand right hand members. Further, it is possible to utilize a tool thatuses only a single suture carrier and guides the carrier through bothsides of the wound as opposed to the double suture carrier configurationdescribed above.

[0042] Referring to FIG. 2A, a formed tip 234 (such as the formed tip 6described above and the one described hereinafter) comprises a body 236having a shoulder 238. The shoulder 238 is the rear surface of theformed tip body 236 that engages a catch. A length of suture material242 is inserted into a hole 244 located on the shoulder 238 and attachedto the formed tip 234 thereby. The suturing material 242 is attached tothe body 236 by any suitable means, such as crimping or adhesivebonding. The rectangular shaped body 236 is merely illustrative, and theshape may be varied to fit a particular application. For example, asimple elongated cylinder or a triangular block may be used, as shown inFIGS. 2B-2E. The formed tip 234 can be manufactured from a plastic,metal, or polymer compound and can be formed by, for example, extrusion,molding, or machining. Furthermore, the type of material(s) used to formthe suture is not critical to the present invention, as long as thematerial(s) used is/are biocompatible. The formed tip 234 of the presentinvention may be used with any type or size (length, cross-sectionalshape) of suture material. The surgeon will select the length, diameter,and characteristics of the suture to suit a particular application.

[0043] Various possible formed tips according to the invention are nowdescribed with reference to FIGS. 2B-2H.

[0044] In FIG. 2B, the suture 242 is shown attached to an elongatedcylindrically-shaped body 235, which may illustratively be somewhatrigid, at least as compared to the suture 242, to facilitate capture bya catch. As illustrated in FIG. 2C, an end portion of the suture 242 maybe molded or otherwise formed within the body 235 of the formed tip.

[0045] In FIGS. 2D and 2E, the body 237 has a generally triangularcross-sectional shape and is shown attached to the suture 242. It willbe appreciated that the suture 242 may be inserted into a mold in whicha plastic or plastic-like material of the body 237 is injected.Alternatively, the suture 242 may be held within a hole 245 within thebody 237 by adhesive bonding.

[0046] FIGS. 2F-2H show how a body 239 may be clamped downwardly on asuture 242 and welded or otherwise pressure formed and closed to capturethe suture 242. The body 239 is an elongated member having a C-shapedcross-section, as shown in FIG. 2F, to receive the suture 242. The body239 may have a plurality of ridges 241 as shown to grip the suture 242when the C-shaped body 239 is clamped with forces F as shown in FIG. 2Gto produce the cross sectional shape shown in FIG. 2H. Techniques forwelding or joining plastic by the application of pressure and energy tocapture another material, such as a suture, are well known.

[0047] Referring now to FIG. 3A, a suture carrier 246 (such as thesuture carriers described above and the one described hereinafter)comprises a body 248 defining a lumen 259, a notch 250 to receive aformed tip 234, and a sharpened end 252 for tissue penetration. Formingor machining may be used to fabricate the sharpened end 252. The lumen259 is in communication with the notch 250 at one end and with anaperture 258 at the other end. The notch 250 is sized and shaped toreleasably engage the formed tip 234. A length of suture material 242attached to the formed suture tip 234 is inserted into the notch 250,through the lumen 259, and out the aperture 258. The attached formed tip234 is then releasably engaged with the notch 250. Alternatively, thesuture carrier 246 can be a solid piece with the suture 242 disposed ina groove in the outer surface of the suture carrier 246.

[0048]FIG. 3B depicts an enlarged view of the tip of the suture carrier246. The formed tip 234 is releasably engaged with the notch 250 so thatthe body 236 protrudes slightly from the notch 250. The rear surface ofthe body 236, which forms the shoulder 238, faces away from thesharpened tip 252. The formed tip 234 is engaged with the notch 250 suchthat the body 234 is held in place by frictional forces when the suturecarrier 246 is extended forward. The body 236 is released from the notch250 when the suture carrier 246 is retracted from a catch. The shoulder238 is dimensioned so as to be retained by the catch when the suturecarrier 246 exits the catch. The interaction of the suture carrier 246and various catches is described in greater detail with respect to FIGS.4 and 5.

[0049]FIGS. 4 and 5 depict alternate catches and illustrate theiroperation. Referring to FIG. 4, the catch 260 includes openings 262defined by successive ribs 264. The catch 260 receives a suture carrier246 (not shown) and a suture 242 with a formed tip 234 through opening262, the ribs 264 deflect slightly to allow the suture carrier 246 andformed tip 236 to pass through. After the formed tip shoulder 238 haspassed the ribs 264 and the suture carrier 246 has been withdrawn,thereby releasing the formed tip 234, the ribs 264 spring back to theiroriginal position defining the openings 262. The openings 262 are chosento be smaller in dimension than the formed tip shoulder 238. This causesthe catch 260 to retain the formed tip 234, because due to the flat rearsurface of the shoulder 238, the formed tip 236 cannot pass back throughan opening 262. When it is necessary to remove the formed tip 234 fromthe catch 260, it may be moved toward an enlarged portion 265 of opening262. The enlarged portion 265 is sized to allow the formed tip shoulder238 to pass through without resistance. The catch 260 is preferablyconstructed of thin stainless steel of high temper, such as ANSI 301full hard. The catch 260 may be fabricated by means of stamping, lasermachining, or chemical etching.

[0050] Referring now to FIG. 5, a catch 266 includes a frame 268 towhich is attached a woven mesh 270. Threads 272 creating the woven mesh270 may be nylon, polyester, or the like woven in a common over/underpattern. The weaving of the threads 272 creates windows 274 in the meshthrough which a suture carrier 246 may be passed. The suture carrier 246is constructed such that the shoulder 238 of the formed tip 234 islarger than the windows 274, or conversely, the windows 274 are chosento be smaller than the shoulder 238. The sharpened end 252 of the suturecarrier 246 pushes the threads 272 aside creating room for the shoulder238 to pass through the windows 274. Upon withdrawal of the suturecarrier 246, the threads 272 return to their original positions and thecatch 266 retains the formed tip 234 (once again due to the flat rearsurface of the shoulder 238, which is larger than the windows 274).

[0051]FIGS. 6A and 6B depict one embodiment of a suture carrier andcatch system. Referring to FIG. 6A, an elongate body member 718 isformed of two complementary housing halves 720 a,b. It is to beunderstood that for clarity only one of the housing halves 720 a of theelongate body member 718 is shown in FIGS. 6A and 6B. The housing halves720 a,b are configured to create a guided pathway 722 that includes asuture carrier channel 724 and a flexible carrier driver guide track726. A suture carrier 728 and flexible carrier driver 730 are joined atan end 732 of the suture carrier 728. Crimping, welding, adhesivebonding, or various other techniques can accomplish the attachmentbetween the suture carrier 728 and the flexible carrier driver 730 atthe end 732. A formed tip 734 and a length of suture material 742 areattached to the suture carrier 728. Further incorporated in the housinghalves 720 are a pair of catch pockets 746 a,b, which position andretain a catch 748. Referring to FIG. 7, the catch 748 includes openings750 defined by ribs 752. The configuration and function of the formedtip catch 748 is similar to that described earlier with respect to FIG.4. When the catch 748 is fabricated by means of chemical etching, thepreferred method is to etch from a single side, known in the art assingle sided etching. When the catch 748 is etched from a single side,the ribs 752 have a tapered cross-section 753 as shown in FIG. 8. Thetapered cross section 753 helps to guide the sharpened end of the suturecarrier 728 into the catch openings 750, thereby minimizing the chanceof the sharpened end of the suture carrier 728 hitting the top of theribs 752.

[0052] With renewed reference to FIGS. 6A and 6B, the operation of thisembodiment will be described. FIG. 6A shows the formed tip 734 loadedinto the suture carrier 728, which is depicted in the retractedposition. In this position, the body 718 may be passed through asurgical trocar and into a body cavity for operation of the device. Asshown in FIG. 6B, as the flexible carrier driver 730 is advanced intothe suture carrier channel 724, the suture carrier 728, holding theformed tip 734 and trailing the suture 742, is driven in a semi-circularpath that intersects the catch 748. The formed tip 734 is received andretained by the catch 748 in a manner previously described with respectto FIG. 4. The flexible carrier driver 730 may be retracted back intothe flexible carrier driver guide track 726, causing the suture carrier728 to rotate back into the suture carrier channel 724. The instrumentmay be removed from the surgical trocar, and the process repeated on theother side of the wound.

[0053]FIGS. 6C and 6D depict an alternate suture carrier and catchsystem. Referring to FIG. 6C, an elongate body member 770 is comprisedof a pair of complementary housing halves 772 a,b. It is to beunderstood that for clarity only one of the housing halves 772 a of thebody 770 is shown in FIGS. 6C and 6D. The housing halves 772 a,b areconfigured to create a guided pathway 774 that defines a suture carrierchannel 776 and a flexible carrier driver guide track 778. A suturecarrier 780 and flexible carrier driver 782 are joined at a saddle 784of the suture carrier 780. The saddle 784 comprises a channel, groove,or opening formed in the proximate end of the suture carrier 780 intowhich the flexible carrier driver 782 may enter. Crimping, welding,adhesive bonding, or various other techniques can accomplish theattachment between the suture carrier 780 and the flexible carrierdriver 782 at the saddle 784. A formed tip 790 and a length of suturematerial 794 are attached to the suture carrier 780. Furtherincorporated in the housing halves 772 a,b are a pair of catch pockets798 a,b that position and retain a catch 800. The configuration andfunction of the catch 800 is similar to that described earlier withrespect to FIG. 4. The suture carrier 780 carries the formed tip 790 ofthe suture through the tissue and into the catch 800 as previouslydescribed.

[0054] Although the operation of this embodiment is similar to thatdescribed in FIGS. 6A and 6B, there are some differences. Referring backto FIGS. 6A and 6B, as the suture carrier 728 approaches the end of itsstroke, as illustrated in FIG. 6B, the circumferential length of thesuture carrier 728 left inside the suture carrier channel 724 isminimal. This may allow the suture carrier 728 holding the formed tip734 to drift off of the prescribed arcuate path that terminates in theformed tip catch 748. This drift may allow the sharpened end of thesuture carrier 728 to miss the catch 748, causing an incomplete suturingcycle. Therefore, it is desirable to increase the circumferential lengthof the suture carrier left inside the guide track in order to improvethe guidance of the suture carrier.

[0055] Accordingly, the embodiment illustrated in FIGS. 6C and 6D equipsthe suture carrier 780 with the saddle 784. The saddle 784 allows theflexible carrier driver 782 to exit from the suture carrier 780 at apoint along the circumference, rather than at a distal end 804. This maybe seen to increase the overall arc length of the suture carrier 780when compared with the suture carrier 728 shown in FIG. 6A. As a result,when the flexible carrier driver 782 is slidably moved in the guidedpathway 774, the suture carrier 780 rotates within the suture carrierchannel 776 such that when the formed tip 790 enters the catch 800, asignificantly larger portion of the suture carrier 780 is still capturedwithin the suture carrier channel 776. This may provide additionalguidance to the suture carrier 780 as it penetrates tissue. Thisgeometry may also allow for a longer stroke length and greater tissuebite.

[0056] Referring to FIG. 9A, the distal end of an elongate body 858 iscomprised of a pair of complementary housing halves 860 a,b. It is to beunderstood that for clarity only one of the housing halves 860 a of thebody 858 is shown in FIG. 9A. The housing halves 860 a,b are configuredto create a guided pathway 862 that defines a suture carrier channel 864and a flexible carrier driver guide track 866. A suture carrier 868includes a saddle 872, to which is attached a carrier bearing 874. Thesaddle 872 comprises a channel, groove, or opening formed in theproximate end of the suture carrier 868 into which the flexible carrierdriver 870 may enter.

[0057] The construction of the suture carrier may be best understood byreferring to FIG. 11A, where a cross-sectional view shows the suturecarrier 868 and the carrier bearing 874. The carrier bearing 874 furtherincludes bearing wings 876 a,b. The carrier bearing 874 may be joined bywelding, adhesive bonding, or the like to the suture carrier 868.

[0058] The suture carrier 868 may also be formed by another method. FIG.11B shows a cross-sectional view of a suture carrier 878 that has beenformed out of, for example a 17-4 stainless steel alloy by a processcalled metal injection molding. This process allows the suture carrier878 to be formed in a monolithic fashion such that the suture carrier878, bearing wings 880 a,b, and saddle are formed as one piece. Otherprocesses such as die casting, investment casting, or powdered metalcould also be used to create a monolithic suture carrier 878.

[0059] Another embodiment of the suture carrier, indicated generally at885 in FIG. 9B, includes a sharpened end 886 at the distal end adaptedto penetrate tissue and a groove 887 at the proximal end adapted tocontain a flexible suture driver 888 as previously described. A seriesof pins 889 a,b, c, d are attached to the sides of the suture carrier885. The pins 889 a,b, c, d are dimensioned to be slidably disposedwithin the groove 884 in the suture carrier channel 864, and to provideguidance and stability to the suture carrier 885 in a fashion similar tothat described with reference to FIG. 9A below.

[0060] Referring again to FIG. 9A, the suture carrier 868 and flexiblecarrier driver 870 are joined as previously described at saddle 872 ofthe suture carrier 868, which incorporates bearing wings 876. The suturecarrier 868 has a sharpened distal end 882 adapted to penetrate tissueas previously described in other embodiments. Alternatively, the suturecarrier 868 may include an aperture located at its distal end forreceiving a surgical needle, the needle being permanently attached tothe suture carrier 868. The needle includes a sharpened distal tip and anotch for holding a formed suture tip. The surgical needle can bepermanently attached to the suture carrier 868 by welding, chemicalbonding, or similar technique. In this embodiment, the suture carrierguide track 864 further incorporates a groove 884 adapted to receive thebearing wings 876 a,b. FIG. 12 depicts a detailed cross-sectional viewof the groove 884 and the bearing wings 876. FIG. 13 depicts a detailedcross-sectional view of the suture carrier guide track 864 andillustrates an area of the suture carrier 868 and of the suture carrierguide track 864 where there are no bearing wings 876. It should beunderstood that the cross-section shown in FIG. 13 of the suture carrier868 could be of solid material instead of tubular material if thecross-section were illustrating a monolithic part, such as suturecarrier 878. It may also be understood from the foregoing illustrations,that the width and depth of the bearing wings 876 a,b shown in FIG. 1Aand the bearing wings 880 a,b shown in FIG. 11B are not to be taken asliteral illustrations of the physical dimensions of those features, asthe width and depth may be varied in order to achieve more or lessguidance and bearing surface area as the designer deems appropriate.

[0061] The operation of the embodiment described in FIGS. 9A through 13is identical to that previously described in FIGS. 6C and 6D, with theexception that the bearing wings 876 a,b are adapted to rotationallyslide in the grooves 884 a,b of the housing halves 860 a,b. Thisprovides axial and torsional guidance and resistance to deflection ofthe suture carrier 868 from the anticipated path. Performanceimprovements over the embodiment described in FIGS. 6C and 6D relateprimarily to an increased ability to torque and/or lift the device whilethe suture carrier is exposed to the tissue to be sutured.

[0062] The preferred material for the flexible carrier driver 870 is analloy of nickel and titanium known in the art as nitinol. This materialhas both austenitic and martensitic forms, and can be alloyed to exhibitproperties of both forms as the material moves through a transitiontemperature that can be varied. The martensitic form of the alloy, whenprocessed into, for example wire, has a lead-solder like consistency andeasily deflects plastically to a certain point, beyond which aconsiderable amount of force is necessary to cause further deflection.This elastic behavior is what allows the material to be both flexibleand exhibit high column strength when properly constrained. Thus, theflexible carrier driver 870 is constrained in a track that allows it tobe moved axially, but constrains its deflection off-axis.

[0063] Another embodiment of the invention is shown in FIGS. 14-18. Thisembodiment of the present invention is particularly well suited for,e.g., the fixation of sutures to the Cooper's ligament during theperformance of a Burch bladder neck suspension via a transvaginalapproach. As will become apparent, this embodiment includes features forlimiting the depth of the sharpened end penetration for placing suturesin, for example, ligaments lying directly on bone, and for accommodatingthe anatomy of, for example, the female pelvis.

[0064]FIG. 14 depicts a suturing instrument 300 including a pair ofhandles 302 a,b, an elongate body 304, distal tips 306 a,b, and anactuator button 308. FIG. 15 depicts the suturing instrument 300, thehandle 302 a, the elongate body 304, the distal tip 306 a, and theactuator button 308 in cross-section. The actuator button 308 includes abutton head 310, a button shaft 312, a series of button bearing surfaces314 a,b, c, d, a button end 316, and a hole 318. The button bearingsurfaces 314 a,b,c,d ride along a cylindrical surface 320 that is formedby the inside diameter of the elongate body 304. A wireform 322 isinserted into the hole 318, coupling it to the actuator button 308. Aspring 324 encircles the wireform 322, abuts the button end 316, and iscompressed between the button end 316 and a spring washer 326. Thespring washer 326 is seated upon a center tube 328. The center tube 328is housed by the cylindrical surface 320 and is constrained at thedistal end by the distal tip 306. A pusher wire 330 is attached to thewireform 322 by means of a weld, a coupling, adhesive, or other means,and is slidably disposed within a proximal guidance sleeve 332 and adistal guidance sleeve 334, said sleeves 332, 334 being disposed withina cylindrical surface 336 formed by the inside diameter of the centertube 328.

[0065] The pusher wire 330 is preferably constructed of nitinol wire, sochosen as previously discussed for its combination of properties thatallow for bendability and high column strength when constrained. Theconstraints in this construction are provided by the proximal guidancesleeve 332 and the distal guidance sleeve 334.

[0066]FIG. 16 depicts the distal end of the suturing device 300. For thepurposes of clarity, only one of the distal tips 306 a is shown andcross-sectional representations of the center tube 328, the distal guidetube 334, and the elongate outer tube 304 are shown. The pusher wire 330is attached by welding or other means to a coupling 338, which isslidably disposed within a track 340. The coupling 338 is also attachedto a carrier wire 342, which by virtue of its attachment to the coupling338, is also slidably disposed within the track 340. The carrier wire342 is attached to a suture carrier 344 by welding or other means. Thecarrier 344 is rotatably and slidably disposed within a suture carrierchannel 346 molded into the distal tip 306. The relationship between thecarrier wire 342, the carrier 344, and the channel 346 is similar tothat previously described in FIGS. 9-13. The coupling 338 abuts abackstop washer 348 that is slidably disposed about the pusher wire 330,and constrained within a pocket 350. The pocket 350 includes a back wall352, against which the backstop washer 348 rests.

[0067] The track 340 terminates distally in a pocket 354 that includes awall 356. A downstop washer 358 is slidably disposed about the carrierwire 342 and constrained within the pocket 354. Positioned at theterminus of the path of the carrier 344 is a catch 360 that is helddistally in a pocket 362 and proximally in a pocket 364. The catch 360is similar in construction and function to the catch described withrespect to FIGS. 4, 7, and 8. The distal tips 306 a,b are held togetherby rivets placed in rivet holes 366 a,b,c,d and by tip shafts 368 a,bbeing inserted into the cylindrical surface 320, which is the insidediameter of the elongate body 304. A depression 370 in the elongate body304 may be formed by mechanical means such as striking with a pin orforming with a die. The depression 370 is engaged in a rotation pocket372 a,b that is formed as a feature of the distal tips 306 a,b, and willbe further described with respect to FIGS. 18A-18B.

[0068] FIGS. 17A-17D depict a sequence of operation of the suturinginstrument shown in FIGS. 14-16. Although this description relates to aspecific application, i.e., the performance of a Modified Burch bladderneck suspension via a transvaginal approach, it is to be understood thatthe principles and construction herein described may be applied to otherareas of the human body, and for other procedures requiring suturingbody structures, such as ligaments that are in direct communication withbone. FIG. 17A depicts a cross-sectional view of the distal tip of thesuturing device 300. The suturing device 300 is shown with a suture 374attached to a suture formed tip 376 in a manner similar to thatdescribed with respect to FIG. 2 and is shown loaded into the suturecarrier 344 in preparation for actuation. The suturing device 300 hasbeen placed against a ligament 378 that lies directly on a bone 380.Referring to FIGS. 15 and 17A, it may be seen that the pusher wire 330is held in tension by the spring 324, as the coupling 338 shown in FIG.17A abuts the backstop washer 348 that is held against the back wall352, positioning the suture carrier 344 in its retracted position.

[0069] As those skilled in the art will appreciate, it can be quitedifficult to drive a suture through a ligament that lies directly onbone, as the bone's density typically does not allow a suture needle topenetrate it. Thus a skimming path should be taken to avoid hittingbone, but ensuring good penetration of the ligament and a subsequent“good bite” of tissue. In the case of the Cooper's ligament that is thefocus of the anterior fixation point for the Modified Burch bladder necksuspension procedure, the difficulty in placing those sutures isdirectly attributable to the ligament lying on the bone and the problemswith exposure of the ligament to the surgeon.

[0070] Again referring to FIG. 15, and now FIG. 17B, the actuator button308 is depressed by pushing on button head 310, which via attachment tothe wireform 322 is attached to pusher wire 330, which moves coupling338 along track 340 while concomitantly moving the carrier wire 342,which slidably and rotatably moves the suture carrier 344 in the channel346 and drives the sharpened end of the suture carrier 344 into theligament 378. The suture carrier 344 skims or slides along the surfaceof the bone 380, maximizing the depth of penetration, but not digging inor penetrating the bone surface.

[0071] Referring now to FIG. 17C, the coupling 338 reaches a point inits travel along the track 340 where it pushes the downstop washer 358against the wall 356 of the pocket 354. This action limits the outwardtravel of the suture carrier 344 to prevent overdriving and reduces oreliminates the possibility of expelling the suture carrier 344 from thedistal tip 306. The suture carrier 344 drives the formed tip 376 andattached suture 374 through ligament 378 and into the catch 360, whereit is received and retained in a manner previously described. As thebutton 308 is released, the spring 324 urges the button 308 proximally,moving the pusher wire 330, the coupling 338, the carrier wire 342, andthe suture carrier 344 along with it to the position shown in FIG. 17D,where the backstop washer 348 arrests the proximal movement in a mannerpreviously described, leaving the formed tip 376 in the catch 360 andthe suture 374 driven through the ligament 378.

[0072] A variation of this embodiment can be seen with respect to FIGS.10 and 16. In the embodiment shown in FIG. 10, the path of the suturecarrier 868, illustrated by a phantom line in FIG. 10, exits the housing860 in a direction that is substantially perpendicular to the surface ofthe housing 860 and presents an opportunity for the suture carrier 868to be driven directly into the tissue surface placed against the exitport. Thus, if there were bone immediately underlying that tissue, thiswould allow the sharpened end of the suture carrier 868 to be drivendirectly into bone. In the embodiment shown in FIG. 16, a phantom lineillustrates a different type of carrier path. In this embodiment, thecarrier path exits the distal tip 306 in a direction that approachesbeing substantially tangential to the surface of the distal tip 306.This substantially tangential exit path allows this instrument toachieve the skimming tissue bite referred to earlier. As shown in FIGS.17A-17D, when the surface surrounding the exit port of this device isplaced next to a tissue surface, the sharpened end of the suture carrier344 takes a skimming tissue bite, thereby minimizing any possiblepenetration of bone underlying the tissue.

[0073] Another aspect of this embodiment which is advantageous to thefunction of the device is the ability to rotate the distal tip 306 ofthe instrument relative to the elongate body 304, thereby allowing theinstrument to conform to the contours of, for example, the pelvic brim.This is accomplished by incorporating the construction illustrated inFIGS. 18A and 18B. For clarity, the elongate body 304 has been shown inpartial cross-section so that the depression 370 may be seen to engagethe rotation pockets 372 a,b. This engagement couples the distal tips306 a,b to the elongate body 304, as previously described, and alsoallows the assembly of the distal tips 306 a,b to be rotated axiallyalong the cylindrical surface 320.

[0074] In yet another embodiment, the instrument can be adapted tofacilitate access into the abdominal cavity and the placement ofsuture(s) radially in a body lumen. Such instrument may be particularlyuseful where anastomosis is required such as urethral anastomosisfollowing radical prostatectomy or in blood vessel or bowel anastomosis.Referring to FIGS. 19A-19C, the suturing instrument 66 includes anelongated body member 82 and a rotatable head 124. The elongated bodymember 82 can include an elbow 122 (or bend). The head 124 rotates byangular increments. The elongated body member 82 includes an engagingelement located at its distal end 128. The head 124 includes an engagingelement located at its proximal end 126 for mating with the engagingelement of the elongated body member 82. The head 124 includes a dilatorcap or a bullet-shaped end at the distal end 130 of the head 124 tomaintain the urethra or any other body lumen in a dilated configuration.The rotation of the head 124 is performed manually between eachapplication of a suture in a body lumen and before reloading with theneedle and suture to permit application of a series of sutures along thecircumference of the lumen, at incremental angular positions that can beas small as 10°. The embodiment of the suturing instrument featuring anelbow and rotatable head is particularly adapted to perform suturingafter removal of the prostate to connect the bladder to the urethra orgenerally following any other type of resection.

[0075] In one embodiment, the rotatability of the head 124 isaccomplished with the structure depicted in FIGS. 19D-19F. The head 124includes an engaging element with a male configuration 123. The maleconfiguration 123 includes a series of fluted cuts 133 located along330° of its perimeter. The male configuration 123 includes a stop toprevent the head 124 from rotating 360°. The elongated body member 82includes an engaging element with a female configuration 125 and aflexible detent 131. The female configuration 125 is a substantiallycircular recess with the flexible detent 131 mounted within theelongated body member 82 and protruding into the substantially circularrecess. The flexible detent 131 can be a length of spring wire or a pinand can be made of nitinol. The head 124 can be positioned by rotatingthe male configuration 123 engaging element with respect to the femaleconfiguration 125 engaging element, deflecting the flexible detent 131,and then allowing the flexible detent 131 to mechanically engage thefluted cut 133 which corresponds to the desired angular orientation. Thehead can be positioned in angular increments of 30°. In addition, thehead 124 depicted in FIGS. 19D-19F includes a suture carrier 127 and acatch mechanism 129, which perform substantially the same and areconstructed substantially the same as the prior-described suturecarriers and catches.

[0076] Having described certain embodiments of the invention, it will beapparent to those of ordinary skill in the art that other embodimentsincorporating the concepts disclosed herein can be used withoutdeparting from the spirit and the scope of the invention. Accordingly,the described embodiments are to be considered in all respects only asillustrative and not restrictive.

What is claimed is:
 1. A suturing instrument comprising: an elongatebody member; a suture deployment system disposed at a distal portion ofthe elongate body member, the suture deployment system comprising asuture carrier including a sharpened distal end for tissue penetrationand a notch for holding a formed suture tip; and a catch disposed on theelongate body member to receive and retain the formed suture tip.
 2. Asuturing instrument as defined in claim 1, further comprising adeployment controller including a distal end, the deployment controllerextending substantially along a longitudinal axis of the elongate bodymember to the distal portion of the elongate body member where thedistal end of the deployment controller is coupled to the suture carrierand moves the suture carrier between a retracted position and a deployedposition.
 3. A suturing instrument as defined in claim 2, wherein aproximal end of the deployment controller is coupled to an actuator. 4.A suturing instrument as defined in claim 2, wherein the deploymentcontroller guides the suture carrier along a path that includes aproximal curved path segment such that the suture carrier initiallytravels away from the elongate body member and then towards the elongatebody member.
 5. A suturing instrument as defined in claim 1, furthercomprising a second suture carrier.
 6. A suturing instrument as definedin claim 1, further comprising a suture with the formed tip.
 7. Asuturing instrument as defined in claim 6, wherein the formed tip isconstructed from a material selected from a group consisting of plastic,metal, and polymer compound.
 8. A suturing instrument as defined inclaim 1, wherein the catch is positioned on the elongate body membersuch that a distal path segment of the suture carrier's path isintercepted by the catch.
 9. A suturing instrument as defined in claim2, wherein the deployment controller is coupled to the suture carrierwith a flexible driver member.
 10. A suturing instrument as defined inclaim 9, wherein the flexible driver member further comprises an alloyincluding nickel and titanium.
 11. A suturing instrument comprising: abody member defining a suture exit port and a suture carrier channel;and a suture carrier including a sharpened distal end for tissuepenetration and a notch for holding a formed suture tip, wherein thesuture carrier is movably positioned in the suture carrier channel tomove between a retracted position within an interior region of the bodymember and a deployed position exterior to the body member, the suturecarrier being configured within the suture carrier channel such that thesuture carrier exits the interior region of the body member through thesuture exit port.
 12. A suturing instrument as defined in claim 11further comprising a second suture carrier.
 13. A suturing instrument asdefined in claim 11 further comprising a suture with the formed tip. 14.A suturing instrument as defined in claim 13, wherein the formed tip isconstructed from a material selected from a group consisting of plastic,metal, and polymer compound.
 15. A suturing instrument as defined inclaim 11 further comprising a catch to receive and retain the formedsuture tip and positioned on the body member such that a distal segmentof the suture carrier's path is intercepted by the catch.
 16. A suturinginstrument comprising: an elongate body member having a longitudinalaxis; a distal tip suture deployment assembly joined with a distal endof the elongate body member such that the distal tip suture deploymentassembly is free to rotate axially about the longitudinal axis of theelongate body member, the distal tip suture deployment assemblycomprising a suture exit port formed in the distal tip suture deploymentassembly, a curved suture carrier channel formed in the distal tipsuture deployment assembly, a curved suture carrier movably positionedin the curved suture carrier channel, and a suture with a formed tipcoupled to the suture carrier; and a deployment controller including adistal end, the deployment controller extending substantially along thelongitudinal axis of the elongate body member to a distal end of theelongate body member where the distal end of the deployment controlleris coupled to the distal tip suture deployment assembly and moves thecurved suture carrier through the curved suture carrier channel as thedeployment controller moves between a retracted position and a deployedposition.
 17. A suturing instrument as defined in claim 16, wherein aproximal end of the deployment controller is coupled to an actuator. 18.A suturing instrument as defined in claim 16, wherein the distal tipsuture deployment assembly further comprises a second suture carrier anda second suture exit port.
 19. A suturing instrument as defined in claim16 further comprising a catch to receive and retain the formed suturetip.
 20. A suturing instrument as defined in claim 19, wherein the catchis positioned on the distal tip suture deployment assembly such that adistal segment of the curved suture carrier's path is intercepted by thecatch as the deployment controller approaches the deployed position. 21.A method for placing a suture in tissue comprising the steps of:inserting a suturing instrument enclosing a suture carrier including asharpened distal end for tissue penetration and a notch for holding aformed suture tip, wherein the suture carrier is movably positionedwithin a suture carrier channel adjacent the tissue to be sutured;deploying the suture carrier out of the suturing instrument through anexit port such that the suture carrier exits an interior region of thesuturing instrument through the exit port along a path approximatelytangential to an outer surface of the suturing instrument surroundingthe exit port; and capturing a suture carried by the suture carrier in acatch that receives and retains the formed suture tip.
 22. A suturinginstrument comprising: a body member defining a suture exit port and acarrier channel; a carrier movably positioned in the carrier channelbetween a retracted position within an interior region of the bodymember and a deployed position exterior to the body member such that thecarrier exits the interior region of the body member through the exitport; and a surgical needle permanently fixed on a distal end of thecarrier.
 23. A suturing instrument as defined in claim 22, furthercomprising a suture with a formed tip.
 24. A suturing instrument asdefined in claim 23, wherein a distal end of the permanently fixedneedle comprises a notch for carrying the suture.
 25. A suturinginstrument as defined in claim 23, wherein the formed tip is constructedfrom a material selected from a group consisting of plastic, metal, andpolymer compound.
 26. A suturing instrument as defined in claim 23,further comprising a catch to receive and retain the formed suture tip.27. A suturing instrument as defined in claim 26, wherein the catch ispositioned on the elongate body member such that a distal segment of thecarrier's path is intercepted by the catch.
 28. A suturing instrument asdefined in claim 22, wherein the exit port, suture carrier channel, andcarrier are located in a distal tip assembly coupled to the body member.29. A suturing instrument as defined in claim 28, wherein the distal tipassembly is coupled to the body member such that the distal tip assemblyis free to rotate axially about a longitudinal axis of the body member.